Database management for an orthopedic treatment system

ABSTRACT

A process for treating orthopedic injuries including the steps of presenting a set of treatment protocols; approving a treatment protocol from among the presented set of treatment protocols; capturing information identifying the approved treatment protocol from among the set of presented protocols; and generating information from the captured information into a form compatible with a handheld computer adapted for connection to an orthopedic sensor system. The generated information includes parameters of the identified approved treatment protocol. The process may also include the steps of basing the presented set of treatment protocols upon a database of historic patients, orthopedic injuries, treatment protocols and outcomes, and retaining information about the current patient, the patients injury, treatment protocol and outcome. A system for treating orthopedic injuries with a historic database on a central computer and a handheld computer attached to a sensor system. The handheld computer has formatted treatment protocol parameters originating in the historic database and mediates treatmetn of the orthopedic injury.

BACKGROUND OF THE INVENTION.

[0001] 1. Field of Invention

[0002] The present invention relates to orthopedic treatment processesand, in particular, the present invention relates to preparingorthopedic treatment protocols used in conjunction with computerized ordigitalized orthopedic treatment devices.

[0003] Orthopedic treatment historically involved a physician examiningand diagnosing an orthopedic injury in a patient, prescribing atreatment protocol of activities or exercises for the patient to followin order to facilitate healing, and subsequent re-examination to assesspatient progress. Additionally, the patient was traditionally guided andassisted in following the prescribed treatment protocol by trainedmedical professionals, such as physical therapists, who could inform andadvise the attending physician concerning patient compliance with theprotocol and communicate and assist with the patient to provide desiredactivity details and elicit patient response. The traditional treatmentpath often included either hospitalization or patient visits at aphysical therapy facility.

[0004] In modern times, financial pressure upon the medical arts and thesurrounding medical industry has increased the number of patients eachphysician must treat and reduced the rate of hospitalization andtendency to employ physical therapy facilities, as well as reduced thedirect supervision of the patient activities by the physical therapist.Computerized devices have been developed that at least partiallysubstitute for the physical therapist contact, and yet monitor patientactivities under a treatment protocol. One particularly innovativedevice system, the IZEX sensor-instrumented orthosis and associatedSmart IDEA™ computer/communicator, not only replace much of the physicaltherapist's function of (1) advising and instructing the patient and (2)advising the attending physician of patient compliance, but also allowan improved measuring and monitoring of patient rehabilitationactivities and exercise parameters, such as effort exerted inrehabilitation exercises or stress applied to the orthopedic injury.This improved monitoring enables exploitation of a long observed andliterature documented phenomenon of improved recovery in response toappropriately applied exercises to orthopedic injuries. The topic ofaccelerated and improved recovery through the use of controlledbio-feedback based rehabilitation has been reviewed extensively by oneof the present inventors in patents U.S. Pat. No. 5,052,375; U.S. Pat.No. 5,368,546; U.S. Pat. No. 5,484,389; and U.S. Pat. No. 5,823,975, andthe entire disclosures of these patents are incorporated herein byreference.

[0005] The ultimate goal of efficiency and optimal and acceleratedrecovery outcomes still remains elusive, however, since the utilizationof the IZEX™ orthosis brace system and Smart IDEA™ computer/communicatorcontinues to rely upon physician examination, diagnosis and prescriptionof a treatment protocol for the injured patient. The physician may notreadily know nor have available information concerning the optimaltreatment protocol for an accurately diagnosed injury. It would be asignificant advance in orthopedic treatment if a physician or othertreatment professional could be rapidly advised concerning optimaltreatment information based upon up-to-date experiential outcomes ofsimilar treated injuries. It would also be a significant advance if thephysician or treatment professional could leverage their own expertiseand their colleagues' most recent knowledge to appropriately modify andadapt previously successful protocols to fit a new patient. It wouldalso be a significant advance if the protocol could be installed in ahandheld computer (monitoring device/computer/communicator) device withease and efficiency. Additionally, it would be a significant advance toallow modification, particularly real-time modification, ofrehabilitation exercise protocols by a user or in response to a userrequest, with such modification being limited by reasonable constraints.The following invention provides such advances to the orthopedic arts.

BRIEF DESCRIPTION OF THE FIGURES AND APPENDICES

[0006]FIG. 1 is a schematic diagram of the relationship betweenparticipants and equipment used in the process according to the presentinvention;

[0007]FIG. 2 is a schematic of the steps included in the process of thepresent invention;

[0008]FIG. 3 is a schematic of details of the generation step of FIG. 2;and

[0009]FIG. 4 is a another schematic of the inter-rationships of thesystems of the present invention, especially between external inputs(left column) , the handheld portable computer, for example an IZEXbrand SMART IDEA (center column), and an external fileserver with adatabase (right column.)

[0010] Appendix A is a recorded data format for use in the presentinvention;

[0011] Appendix B is a protocol structure definition for use in thepresent invention;

[0012] Appendix C is another view of various embodiments of anorthopedic treatment system/process/&method of the present invention;and

[0013] Appendix D is another schematic view of the data handing, flow,components and approaches of the present invention.

SUMMARY OF THE INVENTION

[0014] The present invention, in a first embodiment, is a process fortreating an orthopedic injury. The inventive process involves performinga number of steps to generate information about a prescribed protocolfor treating the orthopedic injury of a patient. Such generatedinformation may be in the form of a script, which may be used in ahandheld computer and orthosis device combination to treat an orthopedicinjury. The process steps include:

[0015] a.) Presentation of a set of treatment protocols. The presentedset of protocols includes at least one treatment protocol. Thepresentation might be on a display screen or a paper printout or similarhardcopy or both. (as represented for example in FIG. 2 at “1 a”)

[0016] b.) Approval of a treatment protocol from among the presented setof treatment protocols. This step is undertaken by a treatmentprofessional using professional judgement and, generally, the approvalis made in light of further information about the treatment protocolwhich is being approved. (as represented for example in FIG. 2 at “1 b”)

[0017] c.) Capture information identifying the approved treatmentprotocol of the set of presented protocols. (as represented for examplein FIG. 2 at “1 c”) and.

[0018] d.) Generate information from the captured information into aform compatible with a handheld computer adapted for connection to anorthopedic sensor system, wherein the generated information includesparameters of the identified approved treatment protocol. (asrepresented for example in FIG. 2 at “1 d”)

[0019] Additionally the method may include e.) communication from theportable monitoring and communication device of information concerninginteractions, communication exchange and/or patient exercise; and f.)modification of the treatment protocol; and g.) monitoring the newprotocol..

[0020] The present invention includes a number of further embodiments.One particularly notable embodiment involves a database of historicinformation of earlier patients, their injuries, their actual treatmentsprotocols as performed, and resulting outcomes and a communications anddata method to connect the two optimizing functions together.Information is accumulated in such a database during the process ofcertain embodiments and information from the database is made availableand utilized in other embodiments.

[0021] The present invention in another embodiment is a system fortreating an orthopedic injury. The system includes a handheld computeradapted for connection to an orthopedic sensor system, a centralcomputer including historic database of orthopedic injuries, patientcharacteristics, treatment protocols and outcomes. With the system, thecentral computer is queried to present a set of treatment protocols to atreatment professional. The treatment professional approves a treatmentprotocol of the set and the system generates formatted parameterscorresponding to the approved treatment protocol for installation in thehandheld computer. Once installed with such parameters, the handheldcomputer can mediate the approved treatment protocol when it isconnected to the orthopedic sensor system. The system further includesmonitoring performance of the treatment protocol and updating thehistoric database with the monitored performance parameters. The systemfurther includes modification of the formatted treatment protocolparameters in real-time in response to updates to the historic database.Data which is transmitted to the central computer can be analysedagainst other databases and more channels and sent on for otheranalysis. When the data is sent (COMMUNICATED) secure communication maybe optionally employed.

DETAILED DISCLOSURE OF PREFERRED EMBODIMENTS

[0022] The present invention, in a first embodiment, is a process fortreating an orthopedic injury of a patient under care of a treatmentprofessional. The process is illustrated in FIG. 2 at 10 and FIG. 1 isprovided to depict relationships between participants and equipment incarrying out the inventive process 10. The process 10 includes thefollowing steps:

[0023] First, a set of treatment protocols is presented “1 a” to thetreatment professional 12. The set of treatment protocols to bepresented includes at least one treatment protocol but optionally andoften includes a plurality of treatment protocols which relate to thepatient's orthopedic injury. The presentation step may include,preferably, displaying the set as an image, preferably a set of imageson a computer screen 14, such as a CRT screen or LCD screen, or mayinclude providing a printed copy 14 of the presented set, or may provideboth. The presentation may be graphical, textual or a mixture ofgraphical and textual. Additional information, again graphical, textualor mixed graphic and text may accompany the presentation, for example,in order to provide additional information about the protocol set orindividual protocols of the set. Examples of additional informationwhich may be presented to the treatment professional are historic,statistical, or predicted outcomes. As with the earlier mentionedpresentation of the set, such additional information may be presentedtextually or as a graphic, including a color attribute of a graphic ortext being presented.

[0024] To explain further the step of presentation of the set oftreatments protocols to the treatment profession, consider somepreferred embodiments and a few illustrative examples. One preferredpresentation includes graphical figures or icons on the screen, whereinthe graphical figures are animated such that they facilitate rapidcomprehension of the form of exercise motion being presented. Forexample, in the situation of an orthopedic injury associated with apatient's knee, the treatment professional might be presented with ascreen display having a set of animated graphical figures representingpossible treatment protocols involving the patient's knee performingbending exercises. This may be accomplished by including animatedmovement of either a set of stick-characters' legs with knees bending ora more realistic depiction of side views of legs having bendable orbending knees. In such an animated graphical representation, the degreeof bending of each of the depicted animated knees is presented as ananimated graphic by a series of screens with incremental changes ofscreen positions of one or both of the portions of the leg adjacent theknee. The sequential display of such screens conveys an impression ofmotion, in the form of knee bending, to the treatment professional. Anarcuate arrow using the knee as an axis or pivot point, might showlimits of range of motion for one or more of the bending knees. Textualinformation might also be simultaneously presented, for example, thepatient's name or similar identification might show on the screen aswell as the degree of motion being depicted by the arcuate arrow.Additionally, sounds, such as oral descriptions of the exercisetreatments protocols or associated parameters, including especiallypatient directed voice comments, might be presented or made availablefor presentation with the set, or individual treatment protocols of theset.

[0025] It should be recognized that the ability to directly utilizesound files for patient directed voice comments requires inclusion of aspeaker in the hand-held computer, however, patient directed voicecomments alternatively might be provided as separate analog or digitalrecordings, for example, as cassette tapes or compact disk recordingsand the patient directed to listen by visual information provided by thehand-held computer. Moreover, computerized video files or theavailability to call up a designated computerized video file, may alsobe included in the presentation. As with sound files, the efficiency ofpresentations including video files is dependent on the availability ofsufficient communications “bandwidth.” However, both the treatmentprofessional and patient benefit from such richer or expandablepresentation of the set by rapidly and efficiently comprehending andconsidering choices in available and appropriate treatment protocol forthe patient.

[0026] In a second step, a treatment protocol from amongst the presentedset of treatment protocols is approved by the treatment professional “1b”. In a preferred embodiment, the approval step includes highlighting agraphical representation of the particular treatment protocol selectedfor approval by the treatment professional. This step may be performedefficiently by employing a mouse or similar pointing device to move acursor in a graphical user interface (GUI) and clicking or doubleclicking to highlight and approve the selected treatment protocol.Alternatively, in a textual or mixed textual and graphical interface,each protocol, including each of any number of predesigned, pre-enteredprotocols has a protocol identifier such as a number or letter or nameassociated with the treatment protocol. The protocol identifier for theprotocol which is to be approved is input from a keyboard and entered.Other alternative approval steps may involve a touch screen, lightpen,or voice input. In a most preferred embodiment, the approving stepincludes causing a visual change to the presentation upon a screendisplay and then inputting an “enter” command, either by keyboard, by amouse button click, by a voice command of the treatment professional, orby touching the screen of a touch sensitive screen display.

[0027] Next, the treatment professional's approval of a particulartreatment protocol of the presented set is captured “1 c”. That is,information is captured which identifies the approved treatment protocolof the set of presented protocols. In a first embodiment, the capturedidentification is less than the entire information detailing theapproved treatment protocol, but may be used to retrieve or regeneratethe entire information; in a second embodiment, the captured informationincludes the entire information detailing the treatment protocol. Toaccomplish the capture, a computer program is provided. A computersystem 16 is present, and may be one or more computers; optimally ifseparate computers, the separate computers are linked, for example on anintranet or on the Internet 32. Other programs 28 and 30 are present inthe computer system 16 as will be discussed subsequently. Additionally,a historic database 26, also discussed subsequently, is present in amemory/storage device and available to the computer system 16.

[0028] In the next step “1 d”, information is generated from thecaptured information into a form compatible with a handheld computeradapted for connection to an orthopedic sensor system. The generatedinformation includes parameters and details of the identified approvedtreatment protocol. This step might be understood in terms of atranslation of at least a portion of the information used in thepresentation set or represented by the presentation set into a scriptusable by a handheld device such as a SMART IDEA™ device available fromIZEX Technologies, Inc, Golden Valley Minn. The recorded data format andprotocol structure definition employed for data recording, storage, andsubsequent communication with the SMART IDEA device, are provided inAppendices A and B respectively, and together are examples of a suitablescript for generation by this step. Example of other handheld computerdevices which may be adapted to serve in the role of the handheldcomputer are the PALM PILOT brand series and PALM brand series ofhandheld personal computers available from the 3COM division of U.S.Robotics Corporation, the NINO brand handheld computer of PhillipsElectronics, the JORNADA brand of handheld computers of Hewlett Packard.The SMART IDEA™ device 20 is connectable to a compatible orthosis device22 on the patient 24 to be treated, such orthosis devices have beenpreviously disclosed in U.S. Pat. No. 5,052,375, the entire disclosureof which is hereby incorporated by reference. An orthosis of this typeincludes sensors or a system of sensors. When the sensor system of sucha device is connected to a suitable handheld computer, the step ofmonitoring may be accomplished by receiving a signal from a sensor or asystem of sensors. The process may also be employed with sensorsdirectly attached to the body, (instead of mounted upon and inconjunction with an orthosis,) which communicate by signaling through aconnection to a handheld computer, such as a SMART IDEA™ device.

[0029] The generation step is shown in more detail in FIG. 3 at “1 d”.The input is the captured identification information resulting fromearlier step “1 c”. The program 18 begins with a retrieval 40 of thefull set of protocol parameters for the identified protocol from aprotocol parameters database. The protocol parameters database, in apreferred embodiment, is, or is a subpart of, historic database 26. Next42, the program 18 looks for any modifications or other input from thetreatment professional 12. Possible modifications and input arediscussed subsequently but might include a recording of voiceinstructions to the patient 24. If any modifications or other input arepresent, it is combined with the parameters from the database to form amodified or augmented treatment protocol. The protocol parameters,possibly modified, are then checked 44 against a set of standard checksor safeguards. The source of the safeguard information may be based uponinformation stored in the historic database 26 or a separate database,isolated from the historic database 26. Basis of safeguardinginformation against which the parameters may be checked are statisticalnorms, desired outcome information, biomechanical safety data, parameterinter-relationships, and information generated by querying the database,for example by program 28, to determine whether a simulated outcomeresult is consistent with the predicted outcome previously presented tothe treatment professional 12. Yet another safeguard involved checkingto see whether the protocol parameters are consistent with the handheldcomputer 20 which will be used. This safeguard becomes more significantshould more than one model or type of handheld computer 20 be present inan installed base of handheld computers and variations exist between thecapabilities of the handheld computers 20. For example, if the protocolwere supplying a patient voice communication file or initiator of such afile to a handheld computer 20 which is incapable of playing the file,then the check would generate a prompt to the treatment professional tosubstitute a different instruction set, different equipment, or augmentthe sound limited handheld computer 20 with a compact disk player whichcan be controlled by the handheld computer 20.

[0030] If the safeguard checking fails 46, then the program 18preferably provides for a prompt 48 of the treatment professional 12 toprovide different modifications. The prompt 48 is made by a presentationto the treatment professional 12 that the modification is unacceptable.Newly provided modifications, if any, are then recombined with theoriginal full treatment protocol parameter set 40 to reattempt to createa modified treat protocol parameter set 42. If the check passes, thenthe parameter set is formatted 50 consistent with the script acceptableto the handheld computer 20. Appendices A and B represent a recordeddata format and protocol structure definition consistent and compatiblewith a SMART IDEA device, and may be used in a process according to apreferred embodiment of the present invention.

[0031] Having generated or translated the treatment protocol informationinto an appropriate form, the process has resulted in production of atreatment protocol script by an attending treatment professional in anefficient manner. The treatment protocol script is available and usefulin treating the patient's orthopedic injury. The most useful basicprocess of the present invention may be employed, expanded, andincorporated into several inventive processes, as summarized below.

[0032] In one preferred embodiment of the present invention, the processfurther includes the step of loading 2 the generated information in thehandheld computer 20. Continuing the application involving the SMARTIDEA™ device, the information, in the form of a script would be loadedinto the SMART IDEA™ device. The SMART IDEA™ device would then beavailable for connection to an orthosis which may be attached orpre-attached to the patient. In some situations, the loading may be bydirect connection to the treatment professional's computer, for example,through an RS-232 or PC1 cable connection. In other situations, the twocomputers may separated a considerable distance and the scriptcommunicated over telephone lines through modem connections. In a mostpreferred embodiment, the communication sending the script to load theSMART IDEA™ device would be via the Internet 32, an intranet, or othermulti-media communication network.

[0033] In another preferred embodiment, the process further includes thestep of monitoring 3 patient activity relative to the approved treatmentprotocol and storing data resulting from the monitoring in the handheldcomputer. Continuing the explanation utilizing the SMART IDEA™ device,the patient's exercise activities, most preferably initiated in responseto a patient signal originating from the SMART IDEA™ device, aremonitored and stored in the SMART IDEA™ device. The SMART IDEA™ deviceincludes memory elements allowing for such storage of data.

[0034] In yet another preferred embodiment, the process continues byadding the optional step of processing the stored data from themonitoring, for determination of compliance relative to the approvedtreatment protocol. This embodiment, involving what may be termed“compliance processing” is within the data processing capabilities of aSMART IDEA™ device In still another embodiment, the process furtherincludes the step of communicating information 5 concerning the storedmonitoring data to a central computer. Alternatively, the presentinvention is embodied in a process including the further step ofcommunicating the processed stored data from the monitoring forcompliance relative to the approved treatment protocol to a centralcomputer. These embodiments may be understood as communicating raw dataor processed data from the SMART IDEA™ device to a central computer,respectively. In a preferred embodiment of either of these, theembodiments may communicate their respective data from the SMART IDEA™device to a central computer via the Internet or an intranet. Thecommunication might also involve a combination of raw and processeddata. If raw data is communicated, then the process may further includethe step of processing the communicated information at the centralcomputer. Data processed prior to communication may also be furtherprocessed or reduced at the central computer.

[0035] The data received at the central computer is available forpresentation 7 and preferably includes processed patient monitoring andcompliance information. As with the earlier presentation of the set, thedata may be presented, either on screen or in printed form or both; andthe presented data may be graphically, textually or a combination ofboth. The data may also be used to update 8 a historic database 26 withthe processed patient compliance information. Use of the data forpresentation in order to allow review by a treatment professional or inupdating a historic database are not mutually exclusive, and in a mostpreferred embodiment, both steps are available and utilized in atreatment process according to the present invention. It should beunderstood, that the reviewing treatment professional and the treatmentprofessional involved in the earlier approval step are not necessarilythe same individual. Presented data and updated data may additionally becommunicated and employed for other uses, such as for example,governmental compliance, insurance purposes, and/or financialreimbursement or employment records. Methods of limiting access to thedata in the central computer for confidentiality purposes or financialpurposes are, of course well known, and might include passwords or, inthe case of intranets and private access networks, may also include callback modems as security enhancements.

[0036] In the process of the present invention, the treatment protocolinformation resulting from the script generation step may includeparameters such as an exercise identification parameter, an exercisereplication parameter, and an exercise initiation timing parameter.These parameters serve to define at least part of the treatment protocolapproved from the presented set of treatment protocols.

[0037] Consistent with capabilities of a handheld computer such as, byway of example, the SMART IDEA™ device, the handheld computer may alsoinclude patient signaling capabilities selected from the groupconsisting of audible signaling, visual signaling, and tactilesignaling. Similarly, the handheld computer may include inputcapabilities selected from the group consisting of RS-232 input, sensorsignal input, USB input, modem input, keyboard input, audible input,light input, and Ethernet input. Moreover, the handheld computer mayinclude output capabilities selected from the group consisting of RS-232output, USB output, parallel port output, light output, textual,graphical, audible output, Ethernet input, and tactile output.

[0038] The present invention's usefulness may be further understood inview of some particularly preferred embodiments. In one such embodiment,the presented set of treatment protocols is based upon informationgleaned from a database 26. The database 26 includes a plurality ofhistoric treatment protocol records, the records including fieldspopulated by parameter data for patient characteristics, orthopedicinjury, actual treatment protocol followed by the patient, and historicoutcome. By “historic treatment protocols” herein is meant hereinactual, accomplished and monitored treatment protocols; and by “historicoutcomes” herein is meant the actual, observed recovery or extent ofrecovery resulting from such “historic treatment protocols.”Additionally, in a most particularly preferred embodiment, the database26 further includes parameter data selected from the group ofcharacteristics consisting of patient physical characteristics, patientpsychological characteristics, and prescribed protocol provided to thepatient. In one variation of this treatment process, the presented setof treatment protocols is based upon statistical analysis of data baserecords. In another variation, the presented set of treatment protocolsincludes at least portions of one record of the database. That is, inthe first variation the treatment professional is presented withstatistical information, such as summaries, means, averages, medians orthe like; in the second variation, the treatment professional ispresented with at least portions of one or more records presented, wherethe records are in effect individual case histories. Most preferably,the presented case history records are of patients with similarcharacteristics and similar injuries to the patient about be treated.

[0039] In one embodiment, the treatment professional 12 has the initialopportunity to query the database 26 with at least some parameterscharacteristic of the current patient 24 and the current patient'sorthopedic injury. A computer program 28 is present in the computersystem 16 to query the database 26. This allows the database 26 to besearched for similar case histories in the form of historic records oftreatment protocols and outcomes. Alternatively, the query might be usedto return statistical information relevant to the patient 24. In anextension of these treatment processes, the treatment professional 12may modify the initial query, to increase or decrease the number ofreturned records for presentation. Additionally, the historic database26 may allow queries for predicting the likely outcome of a treatmentprotocol for a patient 24 with a particular set of characteristics and aparticular orthopedic injury. Using this approach, a treatmentprofessional 12 can rapidly investigate the efficacy of a range ofpossible treatment protocols which they might envision for the patient24 with the orthopedic injury. Additionally, once at least one treatmentprotocol is presented, the treatment professional 12 may either modifythe presented protocol or the patient characteristics and eitherre-query the database 26 for likely outcomes or proceed to approve theprotocol. In this process step, it is further provided that thetreatment professional may utilize the query program and historicaldatabase as part of the treatment system of this invention to simulatean evaluation of a treatment protocol under consideration for aparticular patient, then re-modify the treatment protocol based upon thesimulation outputs.

[0040] It is also part of the present invention that the treatmentprofessional may, in modifying the treatment protocol, select fromvarious pre-recorded sound files, one or more patient directed voicecomments, or record one or more individualized i.e. customized voicecomments to the patient. As mentioned previously, the sound files may beplayed later for the patient as part of the treatment protocol orconditionally played as part of the treatment protocol. If the hand-heldcomputer 20 includes the capability to play sound files, then the filesare played via the hand-held computer 20. Alternatively, the handheldcomputer 20 may signal the patient to play the recorded file, forexample, by displaying a message on an LCD screen for the patient to doan added motivational or instructional task such as “Listen side #2cassette recording!” to cause the patient to play an analog cassetterecording of reproduced sound selected by or custom recorded by thetreatment professional. In another variation of this aspect of theprocess, the sound files may be provided to the patient as a set ofsound files on a device in communication with the hand-held computer 20such that the device is instructed to play a particular sound file. Byway of example, this variation may involve a compact disc recording ofone or more sound track files of patient directed comments and acommunication link between the hand-held computer 20 and a compact discplayer device, with the ability to be controlled by the hand-heldcomputer. Such control might be by a direct wire communicationconnection or by an infared signal originated by the handheld computer20. The compact disc may be recorded with generic patient directed voicecomments or customized comments, such as the treatment professional'svoice recording of custom instructions and or encouragement for theparticular patient. In the case of custom instructions, treatmentprotocol modification step, further includes the treatment professionalrecording the customized patient instructions, and the generation step,described earlier, further includes the substep of recording the trackonto a recordable or rewritable compact disc.

[0041] Once approved, the overall process may be continued to capture “1c” and then generate “1 d” information for a handheld computer 20. Thesteps of modifying one or more treatment protocols of a presented setand re-presenting the modified set for availability to the approval stepfacilitates the treatment professional's ability to rapidly andefficiently prescribe a treatment protocol with a high degree ofconfidence.

[0042] Another preferred embodiment of the present invention includesthe additional steps of programming review of the data received from thehandheld computer 20 by the program 30 for compliance with theprescribed treatment protocol as well as for reconsideration of theeffectiveness of the prescribed protocol relative to updates in thedatabase since the treatment protocol was initially prescribed andloaded into the handheld computer. That is, it is entirely feasible thatthe updating of the historic database 26 with information from otherpatients, rather than the patient 24 being treated in this process, willsuggest a modification of the treatment protocol. The newly suggestedmodification may be presented to the treatment professional or,alternatively, a new script automatically generated, communicated to andloaded into the handheld computer 20.

[0043] In another embodiment, failure of the patient 24 to comply withthe treatment protocol may suggest a centrally generated modification,either with or without presentation and review by the treatmentprofessional 12. Failure to comply may include under or over exercisewhich deviates from the treatment protocol.

[0044] In yet another embodiment, the script corresponding to thetreatment protocol may further include conditional logic. In such anembodiment, the conditional logic may be used to provide the criterionfor recognition by the remotely located handheld computer 20 of afailure of compliance by the patient 24 and the ability to alter thetreatment protocol. Alternatively, the conditional logic may be used toprovide criteria for recognition by the remotely located handheldcomputer 20 of meeting or satisfying the treatment goal set by thetreatment professional as represented by the approved treatmentprotocol. The alteration need not be immediately communicated back tothe central computer but might be saved for later communication.

[0045] In still another embodiment, the treatment protocol may includeinformation to generate patient communication signals to alter thepatient's perception of either the protocol's instructions or theurgency of the patient's compliance with the instructions. Suchadditional aspects of the information carried within the scripting beingloaded into the handheld computer 20 can relieve the treatmentprofessional of many time consuming and inefficient contacts with thepatient 24 yet facilitate the patient's compliance.

[0046] For example, patient oral communication files, or parameters tocause patient oral communication files which are pre-installed on thehand-held computer, which might be played to a patient could be includedwith a treatment protocol or a modified treatment protocol. Inparticular, sounds, such as oral encouragement or descriptions of thepatient exercise to be performed, most especially patient directed voicecomments, such as “Keep going Bob; You are almost there!” might beavailable for inclusion in treatment protocols. The ability to modifythe oral comments sound file is particularly useful with real-timemodification for increasing patient compliance with an individualtreatment protocols of the set.

[0047] Although the present invention has been described with referenceto preferred embodiments, workers skilled in the art will recognize thatchanges may be made in form and detail without departing from the spiritand scope of the invention.

What is claimed is:
 1. A process of treating an orthopedic injury, theprocess comprising the steps of. a. presenting a set of treatmentprotocols, wherein the set of protocols includes at least one treatmentprotocol; b. approving a treatment protocol from among the presented setof treatment protocols; c. capturing information identifying theapproved treatment protocol of the set of presented protocols; and d.generating information from the captured information into a formcompatible with a handheld computer adapted for connection to anorthopedic sensor system, wherein the generated information includesparameters of the identified approved treatment protocol.
 2. The processof claim 1 and further comprising the step of: loading the generatedinformation in the handheld computer.
 3. The process of claim 2 andfurther comprising the step of: monitoring patient activity relative tothe approved treatment protocol and storing data resulting from themonitoring in the handheld computer.
 4. The process of claim 3 andfurther comprising the steps of: processing the stored data from themonitoring for compliance relative to the approved treatment protocol.5. The process of claim 3 and further comprising the step of:communicating information concerning the stored monitoring data to acentral computer.
 6. The process of claim 4 and further comprising thestep of: communicating the processed stored data from the monitoring forcompliance relative to the approved treatment protocol to a centralcomputer.
 7. The process of claim 5 and further comprising the step of:processing the communicated information at the central computer.
 8. Theprocess of claim 5 and further comprising the step of: furtherprocessing the communicated information at the central computer.
 9. Theprocess of claim 7 and further comprising the step of: presentingprocessed patient monitoring and compliance information.
 10. The processof claim 7 and further comprising the step of: updating a historicdatabase with the processed patient compliance information.
 11. Theprocess of claim 1 and wherein the step of presenting includes providinga screen display.
 12. The process of claim 1 and wherein the step ofpresenting includes providing a printout.
 13. The process of claim 1 andwherein the step of presenting includes representing a treatmentprotocol parameter as an image selected from the group of imagesconsisting of textual representation, graphic representation, andcombined textual and graphic representation.
 14. The process of claim 11and wherein the step of approving a treatment protocol includes the stepof causing a visual change in the presented screen display.
 15. Theprocess of claim 14 and wherein the step of capturing includes the stepof inputting an “enter” command subsequent to causing a visual change inthe presented screen display.
 16. The process of claim 1 and wherein theparameters of the generated information includes an exerciseidentification parameter, an exercise replication parameter, and anexercise initiation timing parameter, which parameters define at leastpart of the treatment protocol approved from the presented set oftreatment protocols.
 17. The process of claim 1 and wherein the handheldcomputer includes patient signaling capabilities selected from the groupconsisting of audible signaling, visual signaling, and tactilesignaling.
 18. The process of claim 1 and wherein the handheld computerincludes input capabilities selected from the group consisting of RS-232input, sensor signal input, USB input, modem input, keyboard input,audible input, light input, Ethernet input.
 19. The process of claim 1and wherein the handheld computer includes output capabilities selectedfrom the group consisting of RS-232 output, USB output, parallel portoutput, light output, textual output, graphical output, audible output,Ethernet input, tactile output, and hardcopy printer output.
 20. Theprocess of claim 3 and wherein the step of monitoring includes receivinga signal from at least one sensor.
 21. The process of claim 20 andwherein the sensor is mounted on an orthosis device attached to thepatient.
 22. The process of claim 20 and wherein the sensor is directlyattached to the patient.
 23. The process of claim 1 and wherein thepresented set of treatment protocols is based upon information gleanedfrom a database, wherein the database includes a plurality of historictreatment protocol records, the records including fields populated byparameter data for patient characteristics, orthopedic injurycharacteristics, actual treatment protocol followed by the patient, andhistoric outcome.
 24. The process of claim 23 and wherein the databasefurther includes parameter data selected from the group ofcharacteristics consisting of patient physical characteristics, patientpsychological characteristics, and prescribed protocol provided to thepatient.
 25. The process of claim 23 and wherein the presented set oftreatment protocols is based upon statistical analysis of databaserecords.
 26. The process of claim 24 and wherein the presented set oftreatment protocols includes at least portions of one record of thedatabase.
 27. The process of claim 23 and wherein the step of presentinga set of treatment protocols based upon information is gleaned from thedatabase is preceded by the step of: querying the database such that theset of treatment protocols is presented in response to the query, thequery including at least parameters characteristic of the orthopedicinjury of the patient to be treated.
 28. The process of claim 1 andfurther comprising the steps of: modifying a first set of presentedtreatment protocols; and presenting the resulting modified set oftreatment protocols for availability in the approving step.
 29. Theprocess of claim 23 and wherein the presentation includes predictedoutcomes for at least one treatment protocol of the set, the predictedoutcome based upon information derived from the historic database oftreatment protocols.
 30. The process of claim 1 and wherein thegenerated information includes information to cause voice comments to beplayed for a patient.
 31. The process of claim 30 and wherein theinformation generated to cause voice comments is a sound file.
 32. Theprocess of clam 30 and wherein the voice comments are present as soundfiles in the handheld computer.
 33. The process of claim 30 and whereinthe voice comments are present as sound files in a separate device otherthan the handheld computer.
 34. The process of claim 30 and wherein thevoice comments are played conditionally depending upon processedinformation derived from the orthopedic sensor system.
 35. The processof claim 30 and wherein the voice comments are a subset of a moreextensive set of voice comments.
 36. The process of claim 30 and whereinthe voice comments are recorded by a treatment professional approvingthe treatment protocol as an adjunct to the protocol.
 37. A system fortreating an orthopedic injury, comprising: a handheld computer adaptedfor connection to an orthopedic sensor system; a central computerincluding historic database of orthopedic injuries, patientcharacteristics, treatment protocols and outcomes; means to query thecentral computer to present a set of treatment protocols to a treatmentprofessional; means to approve a treatment protocol of the set; and,means to generate formatted parameters corresponding to the approvedtreatment protocol for installation the handheld computer, therebyallowing the handheld to mediate the approved treatment protocol whenconnected to the orthopedic sensor system.
 38. The system of claim 37and further comprising: means to monitor performance of the treatmentprotocol and update the historic database with performance parameters.39. The system of claim 38 and further comprising: means to modify theformatted treatment protocol parameters in real-time in response toupdates to the historic database.